A Year of Change for Tobacco Harm Reduction

Derek Yach

Global Health Strategies LLC

derek@globalhealthconsults.net

Some things never seem to change in the world of tobacco control. At the end of 2021, there are still more than 1 billion smokers in the world, and about 8 million deaths each year from tobacco-related diseases, most of them in lower-to-middle-income countries. The World Health Organization and the Secretariat that oversees the landmark agreement, the Framework Convention on Tobacco Control, was still stressing the need for a nicotine-free world while demonizing tobacco harm reduction (THR) and reduced risk products (RRPs). Politicians and NGOs such as Bloomberg Philanthropies and the Campaign for Tobacco-Free Kids followed suit, warning that such products were a gateway to combustible smoking for credulous youth.

Despite these considerable roadblocks, ‘one small step at a time’ was the mantra for THR in the past year. In the middle of a pandemic, as people sheltered at home and countries closed their borders, as our professional and private worlds shrank to cyber meetings on computer screens, the fact that smokers could benefit from access to RRPs that pose significantly less harm than conventional, toxic cigarettes, became ever-more apparent.

As a former executive director in the WHO’s department of non-communicable diseases, and as one of the players involved in drafting the FCTC between 1998 and 2003, I am ashamed to say that none of us paid much attention to THR at the time. Although the tobacco industry appeared before us while we wrestled with the agreement’s format, smokers themselves were never given such an opportunity. We simply never envisioned the technological disruption that THR would generate, or the products that have the potential to save millions of lives in the interim as we battle to eradicate combustible smoking for good. We saw the world in terms of black and white, with no shades of grey in between.

We were wrong. Advances in science and policy this past year alone have proven there are safer and more effective ways to curb combustible smoking — ways that do not supplant, but rather, augment other products and techniques.

The UK led the way, with its National Health Service now poised to authorize the prescription of e-cigarettes specifically licensed as medical products to help smokers quit their habit, along with NRTs such as patches, gums and sprays — a marriage of THR and practical application other countries can use as a model to shape their own policies. The move comes after a report by the Royal College of Physicians upheld earlier findings that e-cigarettes are useful in helping smokers quit.

The US Food and Drug Administration allowed Vuse e-cigarettes, made by British American Tobacco (BAT), to continue to be sold throughout the country, on the grounds that the sale of these products is “appropriate for the protection of public health.”[i] This precise wording directly challenges WHO’s justification of using an increasingly out of date notion, namely, the existence of “an irreconcilable difference between interests of industry and public health.”

Its long-anticipated decision follows earlier ones that, after rigorous reviews of the scientific data, approved premarket authorizations for Swedish Match’s (SM) snus and Philip Morris International’s IQOS heated tobacco product (HTP) to be marketed as modified risk tobacco products (MRTPs). This means that at least one brand from each of three different categories of THR products — e-cigarettes, snus and heated tobacco products, have passed the FDA’s exhaustive review process.

And the Chinese government recently announced e-cigarette/ENDS regulations — a sharp contrast to governments like India, which have banned them. Given that China produces more cigarettes than do the top five multinational tobacco companies combined, and produces over 90% of all e-cigarette/ENDS devices in the world, these regulations suggest that in time, the country will lead the world in ending smoking.

In complement to these positive developments, THR proponents from around the world came together to share their expertise and produce ground-breaking research that revolves around topics that include how to reduce smoking rates in marginalized communities, and the creation of new revenue streams for tobacco farmers. The Foundation for a Smoke-Free World, a non-profit entity, sponsored much of this work, and as president and CEO, a position I held until October of this year, I am extremely proud of its accomplishments, which include:

- The Report of the Commission to Reignite the Fight Against Smoking, led by US Ambassador James K. Glassman;

- The first-ever compilation of the tobacco harm reduction patent landscape, by Oxfirst;

- Reports on the Global State of Tobacco Harm Reduction by a leading harm reduction NGO;

- The International Network of Nicotine Consumer Organizations, which represents reduced risk users around the world;

- The Center for Agricultural Transformation in Malawi, which is helping tobacco farmers transition their crops;

- The latest iteration of the Tobacco Transformation Index, which shows which companies are making real progress in ending combustibles versus many who are not..

All this work was accomplished despite WHO and its allies unrelentingly disparaging, ostracizing and ignoring Foundation staff members, project grantees, and the studies they generated, all because it is funded through an impenetrable firewall by PMI, one of the companies currently undergoing transformation.

But industry-generated science and patents have advanced our knowledge of the effects of THR, and helped to improve innovations meant to reduce health risks and lower the burden of tobacco-related diseases; the sheer volume of research eclipses that produced by public health researchers.

More than 100 million users of THR products around the world now find their voices through non-governmental organizations formed for this very purpose, with their mantra, “Nothing for us without us.” In other words, no policy should be formed and implemented without the input of those directly affected by it.

That is not all. This past year saw scholarly papers, which stressed that RRPs are effective tools to help smokers lessen their health risk, including one signed by fifteen former presidents of the SRNT. Experts from academia and industry have teamed up to author a study on the impact of the FDA’s recent MRTP designations for RRPs, while younger researchers pleaded to be allowed to follow the science rather than be forced at the start of their careers to choose sides.

Of course, it would be disingenuous of me to omit noting that those sectors of the industry transforming themselves, among them PMI, BAT, SM, and e-cigarette makers Smoore, Relx and JUUL, are doing so, not out of a sudden change of heart, but because it makes good business sense, and addresses investors demands for Environmental, Social & Governance (ESG) criteria to be applied to all sectors. Conversely, state monopolies — countries that own 50% of their domestic tobacco companies outright, or through a subsidiary agency –still lag badly, including some countries that ratified the FCTC. These countries and their state monopolies need to be subject to the same scrutiny now focused on tobacco companies making progress.

WHO’s call after the recent COP9 summit for more focus on smoking cessation measures was good news. But the organization went on undermine itself by continuing to question the role of THR in such an undertaking, with papers presented during the summit itself replete with calls to restrict or ban THR products..

The blind spot continued most recently in a Lancet editorial published after COP9, which lauded the UK for setting the pace in reducing the number of combustible smokers through measures such as taxing tobacco products above inflation, health warnings and plain packaging. Incredibly, missing was any mention of the substantial role e-cigarettes/ENDS have played in this reduction, despite their use having been supported by the RCP, Public Health England and now, the NHS.

This biased attitude is indicative of the THR challenges ahead, which include elaborating on ways to regulate THR products proportionate to the risks they impose on population health, with the goal to accelerate the end of smoking. This principle, commonly used to address environmental threats, incentivizes companies to change for good and penalizes laggards.

In the immediate future, to meet these challenges, it is crucial that the UK share with all countries the steps it has followed to incorporate e-cigarettes/ENDS in its government sponsored programs as an effective smoking cessation tool, and for the FDA, long considered the international gold standard for pharmaceuticals, vaccines and medical devices, to do the same. Just as it shared its rigorous process in bringing COVID-19 vaccines and drugs to market in an accelerated manner, and invested in marketing campaigns for vaccinations, it must publicly acknowledge and communicate to the public at large the dispassionate, scientific reasoning for its decisions to authorize snus, IQOS and Vuse to be marketed as appropriate for the protection of public health.

With this information and additional funding, governments in LMICs can decide which public health communication strategies to use regarding less risky nicotine products, and build their own national research capabilities in support of regulatory policies that are based on the science.

My hopes for 2022 are simple: that in a world where science and innovation is disrupting practice as we once knew it, all parties recognize the world is not black and white. We cannot continue to watch as preventable deaths increase at a time when we have tools to make a difference. We need a bolder vision and concerted action, combined.

To save lives, we need to embrace the grey.

Derek works to advance global health. He draws upon his background in the public, private and non-profit sectors to tackle chronic diseases and mental health.